The medical device industry operates under a complex web of regulations, with 21 CFR Part 820, commonly referred to as the Quality System Regulation (QSR), and ISO 13485 being two of the most significant. Complying with both has created inefficient systems for manufacturers resulting in duplicative efforts and inconsistencies.

Historical Context

The Quality System Regulation (QSR), a component of the FDA's medical device regulations known as 21 CFR 820, went into effect on June 1, 1997. It establishes requirements for quality management systems (QMS) for medical device manufacturers to ensure products meet safety and effectiveness standards. QMSR represents the first significant update to 21 CFR 820 in nearly 30 years.

In the past and continuing to present day, compliance to both the FDA’s QSR and the ISO 13485standard has posed challenges for medical device manufacturers and their clients.

What is QMSR?

In an effort to reduce regulatory workload for medical device manufacturers complying with both the QSR and ISO 13485, the FDA has finalized Quality Management System Regulation (QMSR). The new regulation will go into effect February 2, 2026, combining the FDA’s QSR and ISO 13485:2016 to create a unified directive that aligns U.S. requirements with international standards, streamlining compliance for medical device manufacturers.

Key Changes Introduced by QMSR

The current QSR and ISO 13485:2016 share the goal of ensuring medical devices meet safety standards, but the regulation and standard differ in approach and focus. The QSR focuses on regulatory compliance for medical devices distributed with intended use within the United Stateswhile ISO 13485:2016 is widely required across multiple regions, including Europe, the UK, Canada, the USA, Japan, Australia, ASEAN countries, Latin America, India, and the Middle East, and focuses on compliance and overall effectiveness of the quality management system (QMS).

The QMSR introduces several changes and additions to align 21 CFR 820 more closely with ISO 13485. Fundamentally, QMSR will take on a more structured and risk-based approach with a heavier focus on continuous improvement.

Some key changes or additions address corrective and preventative actions, design and development controls, documentation and record keeping, audits, requirements of management responsibility, product realization, risk management procedures, sterilization process validation, supplier controls, and personnel training. While the final, detailed requirements of the QMSRhave not been released, the FDA has provided an overview of expected changes.

 The QMSR enhances the FDA’s design and development controls requiring compliance of class II, class III, and some class I devices to ISO 13485 Clause 7.3 and its subclauses.

2. Documentation and Record Keeping
Aligning with ISO 13485, the QMSR places greater emphasis on documentation of processes including complaint handling, servicing activities, Unique Device Identification (UDI), and confidentiality matters.

Internal audits in accordance with the QSR have a focus on compliance with regulatory requirements and the scope is largely determined by the manufacturer.
The QMSR requires internal audits to be more aligned with requirements for ISO 13485 internal audits, which assess the effectiveness and compliance of the entire QMS rather than specific aspects of the regulatory system. This means the scope of internal audits will likely include processes of design and development, risk management, production, and post-market activities.

 4. Management Responsibility
The QMSR expands management responsibility by closely aligning with ISO 13485 Clause 4.1, Clause 5 and its subclauses, and Clause 6.1. Top management’s responsibilityextends to establishing a quality policy, establishing objectives, performing management reviews, ensuring resources are available, and communicating requirements to its organization.

5. Training and Competency
Though the FDA’s QSR currently requires training and competency of employees’assigned tasks, the QSR does not provide a detailed scope of training requirements. Ultimately, training requirements under the QSR are left up to interpretation of the manufacturer. The QMSR requires all personnel who impact quality to be trained in accordance with ISO 13485 Clause 6.2 ensuring a training process is followed.

How Should Manufacturers Prepare for Change?

For companies not following ISO 13485 closely, the transition will be complex and resource intensive. Early awareness and preparedness are key to starting the transition. Here are the recommended next steps for manufacturers beginning the transition:

It is important to familiarize oneself with expected changes. While most changes are not drastic, especially if a company is already familiar with both the QSR and ISO 13485, there are many additions and enhancements that will alter company processes.

If a company’s QMS does not closely follow requirements set forth by ISO 13485, comparing the current QMS to the new requirements is fundamental. Once gaps are identified, policies and procedures can be updated or created within an updated QMS to reflect new stipulations.

Employees should be trained to new QMS requirements and should also understand their newest roles and responsibilities in accordance with the updated system. For proper application of new QMS requirements, companies should include an explanation of how specifics regulations impact each given task.

It is important to ensure that suppliers are aware of the latest requirements and are in compliance with the new regulations. Supplier agreements and relationships may need to be reevaluated.

Consulting with regulatory experts to assist with the transition is resource and time effective. Medpoint provides experienced consultants ready to guide companies through this regulatory change.

How Can Medpoint Help?

Reach out to Medpoint today for assistance: https://medpoint.com/contact-us/

Author: Ashlee Bailey, Project Coordinator and Social Media Manager

For more information on the Food and Drug Administration’s Quality System Regulation’s amendments, visit the FDA website.